WASHINGTON, D.C. - The United States Food and Drug Administration has announced new labeling requirements for male condoms made from natural rubber latex without spermicidal lubricant.
In a document issued by the FDA on Dec. 23, 2008, new label recommendations for latex condoms will include example statements regarding unintended pregnancy, sexually transmitted infections, and incorrect or inconsistent use.
These statements will appear in the guidance in italics to make them easier to identify, but the FDA is not recommending italic font be used in actual labeling.
The following is an example of an acceptable set of statements addressing Unintended Pregnancy and Sexually Transmitted Infections:
- Latex condoms do not completely eliminate the risks of pregnancy and sexually transmitted infections (STIs).
- To get the most protection from a latex condom, use one correctly every time you have sex. Please see directions for use inside the package.
- There are many STIs. A latex condom can reduce the risk of STI transmission to or from the head of the penis. However, some STIs can also be spread by other sexual contact. For additional information on STI protection, please read the information inside the package.
- If you believe you have an STI, contact a health care provider. For more information on condoms or STIs, contact a health care provider or public health agency.
According to the FDA, latex condoms must include adequate directions for use to avoid being misbranded. Adequate directions for use will also help address the issue of incorrect or inconsistent use.
The following set of statements is an example of acceptable precautions regarding condom use:
- Do not reuse latex condoms.
- Store latex condoms in a cool, dry place (below 100ºF) and avoid exposure to direct sunlight.
- If the rubber material is sticky or brittle or obviously damaged, do not use the condom.
- If the color is uneven or changed, do not use the condom.
- Make sure there is adequate lubrication. If you add lubricant, use a water-based lubricant. [Manufacturers may identify one or more examples.] DO NOT USE OIL-BASED LUBRICANTS, such as those made with petroleum jelly (e.g., Vaseline ®), mineral oil, vegetable oil, or cold cream, as these may damage the condom.
For more information, visit the FDA's website.
